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Green Tea Extract in Preventing Cervical Cancer in Patients With Human Papillomavirus and Low-Grade Cervical Intraepithelial Neoplasia

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ClinicalTrials.gov Identifier: NCT00303823
Recruitment Status : Completed
First Posted : March 17, 2006
Results First Posted : August 17, 2012
Last Update Posted : May 5, 2015
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Prevention
Conditions Cervical Cancer
Cervical Intraepithelial Neoplasia Grade 1
Human Papilloma Virus Infection
Interventions Drug: placebo
Dietary Supplement: defined green tea catechin extract
Other: laboratory biomarker analysis
Enrollment 98
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Polyphenon E (Defined Green Tea Catechin Extract) Placebo
Hide Arm/Group Description Patients receive oral Polyphenon E daily for 16 weeks Patients receive oral placebo once daily for 16 weeks
Period Title: Overall Study
Started 50 48
Completed 35 38
Not Completed 15 10
Arm/Group Title Polyphenon E Placebo Total
Hide Arm/Group Description [Not Specified] [Not Specified] Total of all reporting groups
Overall Number of Baseline Participants 50 48 98
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 48 participants 98 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
50
 100.0%
48
 100.0%
98
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 50 participants 48 participants 98 participants
28.48  (8.78) 28.27  (8.05) 28.28  (8.39)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 48 participants 98 participants
Female
50
 100.0%
48
 100.0%
98
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 50 participants 48 participants 98 participants
50 48 98
1.Primary Outcome
Title Complete Response - Clearance of Oncogenic Human Papillomavirus (HPV) and Complete Colposcopic, Histologic and Cytologic Clearance of Disease
Hide Description [Not Specified]
Time Frame 4 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Polyphenon E Placebo
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 41 41
Measure Type: Number
Unit of Measure: participants
7 6
2.Primary Outcome
Title Partial Response - Clearance of Oncogenic HPV With Evidence of Low Grade Cervical Intraepithelial Neoplasia
Hide Description [Not Specified]
Time Frame 4 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Polyphenon E Placebo
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 41 41
Measure Type: Number
Unit of Measure: participants
1 6
3.Primary Outcome
Title No Response - Persistent Oncogenic HPV Positivity, With or Without Evidence of Low Grade Cervical Intraepithelial Neoplasia
Hide Description [Not Specified]
Time Frame 4 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Polyphenon E Placebo
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 41 41
Measure Type: Number
Unit of Measure: participants
27 26
4.Primary Outcome
Title Progression - Persistent Oncogenic HPV Positivity, With Evidence of Progression to Worsening Cervical Intraepithelial Neoplasia or Invasive Cancer
Hide Description [Not Specified]
Time Frame 4 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Polyphenon E Placebo
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 41 41
Measure Type: Number
Unit of Measure: participants
6 3
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Polyphenon E Placebo
Hide Arm/Group Description [Not Specified] [Not Specified]
All-Cause Mortality
Polyphenon E Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Polyphenon E Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/50 (0.00%)   1/48 (2.08%) 
Nervous system disorders     
Seizure  0/50 (0.00%)  1/48 (2.08%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Polyphenon E Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   42/50 (84.00%)   34/48 (70.83%) 
Gastrointestinal disorders     
Constipation  2/50 (4.00%)  4/48 (8.33%) 
Diarrhea  1/50 (2.00%)  3/48 (6.25%) 
Flatulence  0/50 (0.00%)  3/48 (6.25%) 
Nausea  16/50 (32.00%)  9/48 (18.75%) 
Vomiting  3/50 (6.00%)  1/48 (2.08%) 
Abdomen pain  2/50 (4.00%)  4/48 (8.33%) 
Stomach pain  6/50 (12.00%)  4/48 (8.33%) 
General disorders     
Fatigue  4/50 (8.00%)  4/48 (8.33%) 
Other pain  1/50 (2.00%)  3/48 (6.25%) 
Infections and infestations     
Cervicitis  6/50 (12.00%)  3/48 (6.25%) 
Sinusitis  3/50 (6.00%)  0/48 (0.00%) 
Investigations     
ALT increased  5/50 (10.00%)  1/48 (2.08%) 
AST increased  4/50 (8.00%)  1/48 (2.08%) 
Musculoskeletal and connective tissue disorders     
Back pain  3/50 (6.00%)  2/48 (4.17%) 
Nervous system disorders     
Dizziness  7/50 (14.00%)  3/48 (6.25%) 
Headache  13/50 (26.00%)  13/48 (27.08%) 
Reproductive system and breast disorders     
Irregular menses  3/50 (6.00%)  2/48 (4.17%) 
Vaginal Discharge  0/50 (0.00%)  4/48 (8.33%) 
Other reproductive system disorders  1/50 (2.00%)  3/48 (6.25%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1/50 (2.00%)  3/48 (6.25%) 
Nasal congestion  0/50 (0.00%)  4/48 (8.33%) 
Other respiratory disorders  4/50 (8.00%)  3/48 (6.25%) 
Sore throat  4/50 (8.00%)  4/48 (8.33%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: H-H. Sherry Chow, Ph.D.
Organization: The University of Arizona
Phone: 520-626-3358
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00303823     History of Changes
Other Study ID Numbers: NCI-2009-00893
NCI-2009-00893 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000458081
HSC 05-40
05-0144-01 ( Other Identifier: Arizona Cancer Center - Tucson )
UAZ03-1-02 ( Other Identifier: DCP )
P30CA023074 ( U.S. NIH Grant/Contract )
N01CN35158 ( U.S. NIH Grant/Contract )
First Submitted: March 15, 2006
First Posted: March 17, 2006
Results First Submitted: July 13, 2012
Results First Posted: August 17, 2012
Last Update Posted: May 5, 2015